AHPA Comments on FDAs Draft Guidance on Claim Substantiation: Focus on Relevance of Traditional Use Evidence

(Silver Spring, MD) -- The American Herbal Products Association (AHPA) today filed comments with the Food and Drug Administration (FDA) to request that FDA recognize the value of credible information on the traditional use of herbs in substantiating structure/function claims for products that contain herbs.

In November 2004, FDA published and requested comments on draft guidance for industry on substantiation of dietary supplement claims (the draft document can be found at http://vm.cfsan.fda.gov/~dms/dsclmgui.html). The Agency stated that the Draft Guidance describes the amount, type, and quality of evidence that FDA recommends a manufacturer have to substantiate a claim under section 403(r)(6) of the Act (e.g., a “structure/function claim”). In addition, the Agency stated that it intends to apply a standard for substantiating dietary supplements claims that is consistent with the FTC's standard of “competent and reliable scientific evidence.”

“FDA should acknowledge that countries all over the world, from Canada to Europe and Australia, have developed policies to allow traditional use claims for herbal products,” said Michael McGuffin, AHPA’s president. “Substantiation of a traditional claim for an herbal product should not require new clinical data so long as the product formulation, dose, and claim conform to established traditional usage records.” AHPA provided in its comments numerous specific examples of monographs and “core-data” files that have been prepared by these international government agencies.

AHPA’s comments also noted that the Federal Trade Commission (FTC) has stated that an option to developing “confirming scientific evidence” for claims based on historical or traditional use is to present such claims “in such a way that consumers understand that the sole basis for the claim is a history of use of the product for a particular purpose,” and “should make sure that the product it is marketing is consistent with the product as traditionally administered.” Similarly, the final report of the Commission on Dietary Supplement Labels recommended that “the composition of the [traditional use] product should correspond with the material for which such claims of historical use may be made,” and would need to be “carefully qualified to prevent misleading consumers.” AHPA expressed support in its comments for the recommendations of the FTC and the Commission.

AHPA’s comments are posted on our website at http://www.ahpa.org/05_0110_AHPAComments_FDA_Substantiation.pdf.


The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry, the only trade association devoted solely to herbal issues. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of responsibility with respect to the way herbs are manufactured, labeled and sold. Website: www.ahpa.org

Karen Robin, Director of Communications
American Herbal Products Association
Telephone: 301-588-1171 x107
Fax: 301-588-1174
Email: [email protected]

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